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OpenTrials
Completed

NCT Number: NCT03122041

Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome

Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.

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Key information

Conditions

PCOS

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old to menopause
  • polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
  • BMI of 30 kg/m2 or higher

Exclusion criteria

  • significant cardiovascular disease
  • significant kidney or hepatic disease
  • personal or family history of medullary thyroid carcinoma
  • known history of gallbladder disease
  • known history of pancreatitis

Treatment and study plan

Sitagliptin

Drug

Other names: Januvia

Lifestyle Intervention

Behavioral

Primary outcomes

  1. The main outcome was change in HOMA-β index (Homeostasis model assessment for beta cell function index).

    Time frame: Homeostasis model assessment for beta cell function index (HOMA-β) was calculated at the base point and after 12 weeks of clinical trial.

Secondary outcomes

  1. The secondary outcome was change in fasting plasma glucose level (G0)

    Time frame: Patient's fasting glucose level was measured at the base point and after 12 weeks of clinical trial.

  2. The secondary outcome was change in plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT).

    Time frame: Patient's plasma glucose level at 120 minutes (G120) after glucose load in oral glucose tolerant test (OGTT) was measured at the base point and after 12 weeks of clinical trial.

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Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance IGT and Type 2 Diabetes T2D in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome PCOS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2017
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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